AZITHROMYCIN PFIZER 250 Milligram Capsules Hard
Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Risalah maklumat
(PIL)
11-05-2024
Ciri produk
(SPC)
11-05-2024
Bahan aktif:
AZITHROMYCIN DIHYDRATE
Boleh didapati daripada:
Pfizer Limited
INN (Nama Antarabangsa):
AZITHROMYCIN DIHYDRATE
Dos:
250 Milligram
Borang farmaseutikal:
Capsules Hard
Jenis preskripsi:
Product subject to prescription which may not be renewed (A)
Status kebenaran:
Authorised
Tarikh kebenaran:
0000-00-00
Ciri produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azithromycin Pfizer 250 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains azithromycin dihydrate equivalent to 250 mg azithromycin.
Also contains 151.55 mg lactose anhydrous
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
White, hard gelatin capsules marked ‘Pfizer’ and ‘ZTM 250’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more
susceptible microorganisms (see section 5.1 Pharmacodynamic properties):
bronchitis
community-acquired pneumonia
sinusitis
pharyngitis/tonsillitis (see section 4.4 Special warnings and precautions for use, regarding streptococcal infections)
otitis media
skin and soft tissue infections
uncomplicated genital infections due to _Chlamydia trachomatis._
Considerations should be given to official guidance regarding the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Azithromycin Pfizer should be given as a single daily dose. In common with many other antibiotics Azithromycin
Pfizer Capsules should be taken at least 1 hour before or 2 hours after food.
CHILDREN OVER 45KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY PATIENTS: The total dose of azithromycin is 1500mg
which should be given over three days (500mg once daily). In uncomplicated genital infections due to _Chlamydia_
_trachomatis_, the dose is 1000mg as a single oral dose.
IN CHILDREN UNDER 45KG BODY WEIGHT: Azithromycin Pfizer Capsules are not suitable for children under 45kg.
RENAL FAILURE:
No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/min).
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